CEU Credits: 0.1
Course Code: ELM-402
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 09/07/2021
Curriculum for this course
Overview
Course structure
Learning objectives
Who should take this course?
Course modules
Overview
Qualification of equipment
Design qualification
User requirement specification
Functional requirement specification
Operational requirements
Vendor qualification
Installation qualification
Installation qualification protocol
Operational qualification
Operational qualification protocol
Performance qualification
Review activity
Overview
What is process validation?
The stages of process validation
Stage 1: Process design
Stage 2: Process validation
Stage 3: Continuous process validation
Review activity
Overview
Traditional Approach
Modern Approach to Process Validation
Traditional vs New Life Cycle Approach to Validation
Quality Risk Management
Quality by Design
Quality by Design (Continued)
Conclusion
Final Exam
Minor Update: Fixed quiz functionality issue
V1.1